JP2007522902A - Nebulizer - Google Patents

Abstract

  The present invention relates to a fluid (2) atomizer (1) used in particular for medical aerosol therapy. In order to simplify the use of the atomizer, the atomizer has a valve device (24) so that the air opening (15) provided in the mouthpiece (13) can be closed.

Description

  The present invention relates to a nebulizer and a mouthpiece for a nebulizer or other inhaler as described in the preamble of claim 1.

  The starting point of the present invention is shown in principle in WO 91/14468, in particular in WO 97/12687 (FIGS. 6A and 6B) and in FIGS. 1 and 2 of the drawings of the present application. It is a nebulizer marketed under the name “Respimat” in the form of an inhaler. The nebulizer has a pressure generator with an insertable container containing fluid as a reservoir for the fluid to be atomized and with a drive spring for conveying and atomizing the fluid.

  For completeness, please refer to the entire disclosure of both WO 91/14468 and WO 97/12687 for completeness. In general, the disclosure of these patent documents is preferably such that the spring pressure applied to the fluid is 5 to 60 MPa, preferably 10 to 50 MPa, the volume delivered in one operation is 10 to 50 μl, preferably 10 to 50 μl, most Preferably about 15 μl nebulizer. The fluid is converted to an aerosol state, and the aerosol droplets have an aerodynamic diameter of up to 20 μm, preferably 3 to 10 μm. Further, the disclosures of these patent documents are preferably in the form of a cylinder with a length of about 9 cm to about 15 cm, a width of about 2 cm to about 5 cm, and a nozzle spray spread of 20 ° to 160 °, preferably It relates to a nebulizer of 80 ° to 100 °. These amounts also apply to the nebulizer of the present invention as particularly preferred values.

  By rotating the actuating member in the form of the lower housing portion of the nebulizer, the drive spring can be tensioned and fluid can be drawn into the pressure chamber of the pressure generator. After manual actuation of the locking element, the fluid in the pressure chamber is pressurized by the drive spring and is expelled through the nozzle and into the mouthpiece without the use of propellant gas or the like to form an aerosol. The velocity of the aerosol cloud is very slow so that the aerosol cloud is virtually stationary within the mouthpiece. The user must then inhale the resulting aerosol as slowly as possible, for example over 10 seconds. The mouthpiece has at least one air supply opening, and the user inhales air from the atmosphere with the resulting aerosol during inhalation through the air supply opening. This creates a supply air and aerosol airflow required for inhalation and an effective amount of aerosol required for the inhalation process.

International Publication No. 91/14468 Pamphlet International Publication No. 97/12687 Pamphlet

  The object of the present invention is to improve the operational safety so that the user can safely inhale or inhale the aerosol even when there is a problem in coordinating the operation of the nebulizer and his inspiration. And providing a mouthpiece.

  The object is solved by a nebulizer according to claim 1 or a mouthpiece according to claim 28.

  Further features are set forth in the dependent claims.

  The basic idea of the present invention is associated with one or more air supply openings so that the nebulizer or mouthpiece can prevent backflow through the one or more air supply openings, i.e. ejection. It has a valve device. Thus, there is an inexpensive and effective way to prevent unwanted release of atomized fluid or aerosol from the mouthpiece through the one or more air supply openings and into the environment as a result of exhalation by the user. Provided.

  The provided valve device preferably directs the user to malfunction when the user exhales (unknowingly) into the mouthpiece to inform the user that they should only exhale when using the nebulizer in the future Overpressure will be created.

  Furthermore, inhalation can be continued after the user has exhaled accidentally too early. This is because the atomized fluid or aerosol still present in the mouthpiece can still be inhaled.

  The above solution is not only the Respimat type nebulizer or inhaler described above, but the resulting aerosol is supplied with air from the atmosphere through a mouthpiece with an air supply opening to achieve the required inhalation volume for the user This also applies to any type of inhaler that must be done. Preferably, the present invention is used in a Respimat type device. In addition to the preferred Respimat itself described in detail below, it is also possible in particular to use nebulizers that do not use propellants and atomize aqueous or alcohol solutions containing the active substance. However, the invention can also be used in nebulizers or inhalers driven by conventional propellants, in particular so-called MDI (metered dose inhalers) and other inhalers.

  According to a particularly preferred feature, the valve device has an associated sensor for detecting the opening or closing or movement of the valve element of the valve device. Thus, the correct use of the nebulizer, for example a sufficiently long and / or strong inhalation, can be detected. The nebulizer preferably has a suitable monitoring device or the like.

  According to another particularly preferred feature, the signaling device, like the pressure generator, operates exclusively mechanically, i.e. without electricity, propellant gas or the like.

  Further advantages, features, properties and aspects of the present invention will become apparent upon reading the following description of preferred embodiments with reference to the drawings.

  In the figures, the same reference signs are used for the same or similar parts, and corresponding or equivalent properties and advantages are achieved even without repeating the description.

  1 and 2 schematically show a known nebulizer 1 for atomizing a fluid 2, in particular a highly effective pharmaceutical composition or medicament, in a non-tensioned state (FIG. 1) and a tensioned state (FIG. 2). Yes. The nebulizer is particularly configured as a portable inhaler and preferably operates without propellant gas.

  When atomizing the fluid 2, preferably a liquid, in particular a pharmaceutical composition, an aerosol is formed which can be inhaled or inhaled by a user (not shown). Usually, inhalation takes place at least once a day, in particular several times a day, preferably at set intervals.

  The nebulizer 1 has an insertable, preferably replaceable container 3 containing a fluid 2, which forms a reservoir for the fluid 2 to be atomised. Preferably, the container 3 contains a quantity of fluid 2 containing a quantity of active substance preparation sufficient to provide, for example, 100 dose units. A typical container 3 as disclosed in WO 96/06011 contains a volume of about 2 to 10 ml.

  The container 3 has a substantially cylindrical or cartridge shape, and once the nebulizer 1 is opened, the container can be inserted into the nebulizer from below and can be replaced if desired. This container is preferably of rigid construction, and the fluid 2 is held in particular in a collapsible bag 4 in the container 3.

  The nebulizer 1 has a pressure generator 5 which carries and atomizes a fluid 2 of a dose b which is particularly preset and can be adjusted arbitrarily. The pressure generator 5 comprises a holder 6 for the container 3, an associated drive spring 7 (only partly shown) with a locking element 8 that can be manually operated and released, and a transport tube 9 with a check valve 10. And a pressure chamber 11 and a discharge nozzle 12 provided in the vicinity of the mouthpiece 13. The container 3 is fixed in the nebulizer 1 by a holder 6, and the transport tube 9 is immersed in the container 3. The holder 6 may be configured so that the container 3 can be exchanged.

  When the drive spring 7 is tensioned in the axial direction, the holder 6 moves downward in the drawing together with the container 3 and the transport tube 9, and the fluid 2 is sucked out of the container 3 and passes through the check valve 10 to generate a pressure generator. 5 into the pressure chamber 11. Since the discharge nozzle 12 has a very narrow flow cross-section, and is particularly configured as a capillary, it will reliably block the intake or intake of air due to suction force at this point, even if no check valve is provided. A powerful throttle action is created.

  During relaxation after activation of the locking element 8, the fluid 2 in the pressure chamber 11 is returned upwards by the relaxation of the drive spring 7 through the conveying tube 9 with the check valve 10 which is now closed, now as a pressure ram. When working, it is pressurized. Due to this pressure, the fluid 2 is pushed through the discharge nozzle 12 where it is atomized into an aerosol 14. The particle droplet size for the Respimat type device has already been described above.

  A user (not shown) can inhale the aerosol 14, during which time supply air can be drawn into the mouthpiece 13 through the at least one supply opening 15.

  The nebulizer 1 has an upper housing part 16 and an inner part 17 rotatable relative to the upper housing part, which inner part has an upper part 17a and a lower part 17b, in particular a manually operable housing part. 18 is preferably releasably secured to the inner part 17 by means of a retaining element 19 and is particularly fitted. The housing part 18 can be removed from the nebulizer 1 to insert and / or replace the container 3.

  The housing part 18 can be rotated counter to the housing part 16, whereby the part 17 b of the inner part 17, which is the lower part in the drawing, is entrained with the housing part 18. Thus, the drive spring 7 is tensioned in the axial direction by a gear (not shown) acting on the holder 6. During tension, the container 3 is moved axially downward until the container 3 assumes the end position as shown in FIG. In this position, the drive spring 7 is tensioned. During the atomization process, the container 3 is returned to its original position by the drive spring 7. Thus, the container 3 takes one stroke during the tensioning process and during atomization.

  The housing part 18 preferably forms a cap-like lower housing part and fits around or on the lower free end of the container 3. When the drive spring 7 is tensioned, the container 3 moves together with its end part into the housing part 1815 (further) or towards its end face, while the axially acting spring provided in the housing part 18. However, when it comes into contact with the base 21 of the container and the container first contacts the piercing element 19, this spring can pierce the seal provided on the container 3 or its base by the piercing element 22 and take in air.

  The nebulizer 1 has a monitoring device 23 that counts the operation of the nebulizer 1, preferably by detecting the rotation of the inner part 17 relative to the upper part 16 of the housing.

  Next, referring to FIGS. 3 to 22, the structure and mode of operation of the nebulizer 1 of the present invention and the container 3 of the present invention will be emphasized only with respect to the essential differences from the nebulizer 1 of FIGS. Will be explained. Accordingly, the description with respect to FIGS. 1 and 2 applies accordingly.

  3 to 6 are schematic cross-sectional views showing details of the nebulizer 1 of the present invention including the valve device 24 of the first embodiment. FIG. 3 shows the valve device 24 in a closed state. FIG. 4 is a detailed view of FIG. 3 along the dotted line. FIG. 5 shows the valve device 24 in an open state. 6 is a detailed view of FIG. 5 along the dotted line.

  In the open state, the valve device 24 has a flow 25 of supply air that enters the mouthpiece 13 through the air supply opening 15 during inhalation, i.e. inhalation, by a user (not shown) of the nebulizer 1 (see FIGS. FIG. 6 shows the corresponding arrows). The user should place the mouthpiece 13 in his mouth and breathe as uniformly and slowly as possible, preferably for a few seconds, in particular about 10 seconds or more, so that the atomizing fluid 2 or aerosol 14 Inhale. In this way, the supply air is inhaled at the same time but is not used to atomize the fluid 2 or produce the aerosol 14. Rather, this is preferably done separately or independently by the pressure generator 5 as described above, preferably without propellant gas.

  In the illustrated embodiment, the valve device 24 is arranged in the mouthpiece 13, preferably beside the discharge nozzle 12 for the fluid 2 or aerosol 14. Alternatively, the valve device 24 may be attached to the exterior of the mouthpiece 13 or may be associated with it in some other way. The external arrangement has the advantage that the valve device 24 is not exposed to the aerosol cloud in the mouthpiece 13, thereby preventing contamination of the valve device 24. Preferably, the valve device 24 is inserted into the mouthpiece 13 in particular as a structural unit or assembly. This valve device can preferably be incorporated later, ie as an add-on (not shown).

  As a variant, at least a part of the valve device 24 is fixedly attached to the nebulizer 1, in particular the mouthpiece 13, preferably formed, injection molded, glued or attached in a similar manner. According to a variant embodiment not shown in detail, the valve device 24 can be exchanged together with the mouthpiece 13. However, in the illustrated embodiment, the mouthpiece 13 is preferably integrally formed with or formed by the nebulizer 1, in particular its upper housing part 16.

  The valve device 24 exits into the atmosphere through the air supply opening 15 (especially that may occur when the user exhales), ie the air flow from the mouthpiece 13 through the air supply opening 15 (supply It is configured in such a way that it can be blocked automatically (reverse to the air flow 25) and is associated with the air supply opening 15. This makes it impossible for the user's exhalation to unnecessarily release the atomized fluid 2 or aerosol 14 through the air supply opening 15 into the atmosphere. On the contrary, the valve device 24 preferably inhales through the mouth of the user (not shown) or through the mouthpiece 13 when the mouthpiece 13 is worn, and the atomizing fluid 2 or the aerosol 14 is It is only possible to increase the probability or probability of inhalation by the user. As a result, operational safety is substantially improved.

  The valve device 24 is preferably configured to operate at least substantially independently of the orientation of the nebulizer 1 in space.

  The valve device 24 may be operated by electrical means, magnetic means, pneumatic means or other means if desired. The valve device 24 preferably operates exclusively mechanically as described below with reference to the preferred embodiment.

  In the first embodiment, the valve device 24 has a preferably plate-shaped seat element 26 and a plate-shaped movable valve element 28 with a through opening 27. The seat 26 is preferably of one-piece construction and is inserted or incorporated into the mouthpiece 13 so that air can only flow into the mouthpiece 13 through the through opening 27. In this manner, the connecting portion to the air supply opening 17 is sealed.

  The movable valve element 28 is associated with the seat element 26 or the through opening 27 to seal the through opening 27 in the closed position shown in FIGS. 3 and 4 to prevent backflow as described above.

  Thus, the seat element 26 and the valve element 28 together form at least one valve 29, in particular a check valve or a one-way valve. However, the valve 29 may also be configured in other suitable ways.

  In the first embodiment, a common seat element 26 and a common valve element 28 are provided for some, in particular all, of the air supply openings 15. However, separate seat elements 26, separate valve elements 28 or valves 29 that operate independently may be associated with the air supply opening 15, as will be described with reference to other embodiments.

  In the first embodiment, the valve element 28 is movable in the longitudinal direction of the nebulizer 1 and / or at least substantially in the direction of the supply air flow 25.

  In the first embodiment, the valve element 28 is biased to the closed position, in particular by a spring force, in the illustrated embodiment by a spring 30, preferably a coil spring. However, it is also possible to use other suitable springs or biasing means instead.

  Alternatively or additionally, the valve element 28 may be biased to the closed position by its own elasticity and / or gravity.

  Furthermore, if necessary, the valve element 28 may also be biased to the open position and / or has two stable positions, in particular a closed position on the one hand and an open position on the other hand. May be.

  In the first embodiment, the valve element 28 preferably has a bar-shaped guide element 31 specifically formed integrally therewith, which guide element is the nebulizer 1, specifically a seating element. It serves to both guide and hold the valve element 28 in a movable state on the two and also to guide or hold the associated spring 30.

  The valve device 24 is preferably configured to open as easily as possible so that the valve element 24 allows for substantially unobstructed inhalation or exhalation. Accordingly, the supply air flow 25 is prevented from being disturbed as much as possible. Therefore, the valve element 28 preferably works easily and in the first embodiment the spring force acting in the closing direction is as small as possible.

  Once the valve device 24 is opened, i.e., with the valve element 28 lifted as shown in FIGS. 5 and 6, the supply air stream 25 is inhaled or inhaled by a user (not shown). , At least for the most part unobstructed, can pass through the air supply opening 15 and then through the through opening 27 into the mouthpiece 13.

  Next, some additional embodiments of the nebulizer of the present invention or the valve device 24 of the present invention will be described with reference to other drawings. In particular, only points that are essentially different from the first embodiment will be described. In other respects, the same characteristics and advantages as in the first embodiment and the known nebulizer 1 apply.

  7 and 8 show a second embodiment of the nebulizer 1 of the present invention and the valve device 24 of the present invention. In FIG. 7, the valve device 24 is closed. In FIG. 8, the valve device 24 is open.

  In the second embodiment, a separate valve element 28 or valve 29 is associated with the air supply opening 15. The valve element 28 is configured as a flap or tongue and is preferably pivotable. The valve element 28 preferably cooperates with a separate seat element 26 to form a valve 29 or directly with an appropriately shaped inner wall of the mouthpiece 13.

  In the second embodiment, the valve element 28 may be biased to the open position if desired. This allows the user to inhale or inhale without interruption. However, when the user exhales into the mouthpiece 13, the valve element 28 is at least substantially instantaneously closed by the resulting backflow, thereby stopping the backflow. The spring force acting in the open position is selected accordingly.

  However, as a modification, in the second embodiment, the valve element 28 may be biased to the closed position as in the first embodiment.

  9 and 10 show a third embodiment of the nebulizer 1 of the present invention or the valve device 24 of the present invention. FIG. 9 shows the valve device 24 in a closed state. FIG. 10 shows the valve device 24 in an open state.

  In the embodiment of FIG. 3, preferably several separate or independently operated valve elements 28 or 29 are again provided, in particular associated with the air supply opening 15.

  As in the second embodiment, the valve element 28 is also configured as a plate or tappet. Preferably, the valve element 28 is guided in a common seat element 26 as in the first embodiment.

  Again, the valve element 28 and the valve 29 are preferably biased to the closed position by a spring 30, in particular a coil spring.

  In the third embodiment, each valve element 28 preferably has a guide element 31 which, on the one hand, preferably receives the valve element 28 as in the first embodiment. 26 to guide and hold the associated spring 30 on the other hand.

  11 and 12 show a fourth embodiment of the nebulizer 1 of the present invention or the valve device 24 of the present invention. FIG. 11 shows the valve device 24 in a closed state. FIG. 12 shows the valve device 24 in an open state. FIG. 12 shows the valve device 24 in an open state.

  The fourth embodiment substantially corresponds to the third embodiment. Only the spring 30 is omitted. Thus, the valve element 28 can move freely or easily and is not particularly biased by a spring force. However, in the illustrated configuration, the valve element 28 can assume a preferred position, i.e., a closed position, as a result of gravity, based on the nebulizer 1 being at least substantially vertically aligned during use. .

  FIGS. 13 to 16 show a fifth embodiment of the nebulizer 1 of the present invention or the valve device 24 of the present invention. FIG. 13 shows the valve device 24 in a closed state. FIG. 14 is a detailed view of FIG. 13 taken along the dotted line. FIG. 15 shows the valve device 24 in an open state. FIG. 16 is a detailed view of FIG. 15 taken along the dotted line.

  The fifth embodiment substantially corresponds to the third embodiment except that the spring structure is essentially modified. The spring 30 is preferably formed as a coil spring, in particular a compression spring. However, in the fifth embodiment, the spring 30 is provided on the side of the seat element 26 located far from the air supply opening 15 and the plate 32 of the valve element 28 is suitable for receiving the associated spring 30. The concave portion 33 has an annular shape in the illustrated embodiment.

  Thus, in the fifth embodiment, the valve element 28 and the valve 29 are preferably biased to the open position. With regard to the configuration and setting of the spring force, the same applies for the second embodiment.

  FIGS. 17 to 21 show a sixth embodiment of the nebulizer 1 of the present invention or the valve device 24 of the present invention. 17 and 18 show the valve device 24 in a closed state. 19 and 20 show the valve device 24 in an open state. FIG. 21 shows a deployment or piece of material 34 that forms the valve element 28 of the valve device 24 according to the sixth embodiment.

  The valve element 28 is elastic and flexible in structure. The tongue-shaped or flap-shaped valve elements 28 in the sixth embodiment take their closed position as their preferred position due to their inherent elasticity, i.e. they close the air supply opening 15. To do.

  During inhalation or inhalation, the valve element 28 is moved or pivoted inward, particularly as shown in FIG. Thus, the air supply opening 15 is opened and air can flow into the mouthpiece 13.

  The valve element 28 is preferably made of the same piece of material 34, in particular foil or other suitable material. However, the valve element 28 may be made from a separate piece of material 34.

  The plan view of FIG. 18 shows a closed state. The valve elements 28 are laid flat, i.e. they are not visible in plan view.

  In the top view shown in FIG. 20, the valve element 28 is shown in an open state and is accordingly turned over or turned in response.

  The plan views of FIGS. 18 and 20 show that the valve device 24 or the piece of material 34 can be enclosed or inserted into the mouthpiece at least in a substantially flat position. As a result, easy and inexpensive assembly is possible, and in particular, the nebulizer 1 can be modified.

  According to another variant embodiment not shown, the valve device 24 or the valve 29 can be moved by the valve element 28 solely by gravity and / or by the air flow 25 or vice versa. It may be configured such that the associated air supply opening 15 can be opened or closed. For example, the valve element 28 is correspondingly connected as a loose sealing element or loose washer or gasket mounted movably in an air supply channel or the like provided adjacent to the air supply opening 15 or in the mouthpiece 13. It should be configured for the purpose. In this way, for example, when the supply air flow 15 is inhaled by a suitable grid, holder, guide, shoulder, throttling portion, etc., the valve element 28 is freely removed from its associated air supply opening 15. Therefore, when the user exhales into the mouthpiece 13, the initial backflow causes the valve element 28 to immediately close the associated air supply opening 15 and thus stop the unwanted backflow It is possible to do so.

  The above-described embodiments show various structural solutions. However, other suitable structural solutions are possible and, if necessary, another valve means 24 may be used instead of the valve device 24 operating purely mechanically.

  An essential feature of the present invention is that the atomization of the fluid 2 or the generation of the aerosol 14 takes place independently of the supply air stream 25. Rather than releasing the aerosol 14 directly through the discharge nozzle 12 and into the mouthpiece 13, the aerosol 14 is first released into some other receiving chamber in the nebulizer 1 and then inhaled or inhaled. At this time, it is transferred to the actual mouthpiece 13 by the flow 25 of the supply air and can be sucked therethrough. Thus, the term “mouthpiece” preferably refers to the receiving or collection chamber of the resulting aerosol 14 to which the term can feed supply air through the air supply opening 15 and is preferably fitted with a tubular portion. It should be broadly understood to mean including, and this tubular portion is then actually fitted into the user's mouth for inhalation or inspiration.

  The preferred features of the seventh embodiment of the nebulizer 1 of the present invention will be described below in detail with reference to FIG. This additional feature can be combined with the above-described embodiments or valve device 24, if desired.

  The nebulizer 1 has a sensor 35 associated with a valve device 24, in particular a movable valve element 28 or at least one valve 29. The sensor 35 serves to detect the open position, closed position and / or movement of the valve device 24, in particular the valve element 28.

  Thus, the sensor 35 also serves to detect movement or at least position of the valve element 28, which is mechanical, optical, electrical, inductive, capacitive and / or other contactless. This is done by means of In particular, the sensor 35 is in the form of a microswitch or a reed contact.

  In the illustrated embodiment, the sensor 35 is provided in the immediate vicinity of or adjacent to the valve element 28 and / or in the mouthpiece 13.

  By means of the sensor 35, the supply air flow 25 is preferably detected indirectly by opening of the valve device 24, at least opening of at least one valve element 28 or valve 29. Thus, the actual inhalation of the aerosol 14 caused by the nebulizer 1 can be detected.

  In addition or alternatively, a so-called flow sensor for directly detecting the air flow may be provided, and this flow sensor may be provided in particular adjacent to the air supply opening 15.

  In the seventh embodiment, the monitoring device 23 is preferably provided in the housing part 18 and / or configured to detect and evaluate the signal from the sensor 35. For this purpose, the monitoring device 23 is preferably electrically operated and the sensor 35 is preferably connected to the monitoring device 23 by electrical or wireless means.

  Detection of the actual inhalation of fluid 2 or aerosol 14 by sensor 35 can be evaluated by monitoring device 23 to ascertain whether the inhalation has been sufficiently long and, if necessary, the inhalation time can be stored and / or displayed. Furthermore, this actual inhalation, in combination with the actual atomization or stroke of the container 3, can be detected or counted, displayed and / or stored as the activation or use of the nebulizer 1.

  However, the monitoring device 23 may also be provided independently of the sensor 35, and such a monitoring device can be operated mechanically, electrically or electronically if necessary.

  The nebulizer 1 of the present invention is preferably configured to use a liquid as the atomized fluid 2.

  The embodiments described above, in particular the individual elements and features of the embodiments, can be combined with each other and / or kinematically reversed.

  The present invention generally refers to an inhalation that produces an aerosol that is virtually stationary or an aerosol cloud at a low exit rate such that the propagation of the aerosol cloud still stands after a few centimeters. The present invention relates to a nebulizer 1. The aerosol cloud exit velocity or at least the initial initial propagation velocity is preferably about 5 to 20 m / min, specifically 10 to 15 m / min, most preferably about 12.5 m / min.

  In particular, due to the low exit velocity or propagation velocity, the supply air stream 25 is necessary to take up the aerosol 14 by inhalation. However, a small supply air flow 25 is preferably sufficient to entrap the aerosol 14 by inhalation.

  In order to enable or guarantee the desired operation of the nebulizer 1 even at low flow rates and / or flow rates, the valve device 24 or its valve element 28 or valve 29 operates relatively easily and can be closed with a particularly small force. The closing force is preferably only a few cN or less. In particular, the closing force is less than 1 cN, most preferably less than 0.5 cN. The closing force can be generated by weight alone due to the inherent elasticity and / or spring biasing force from the spring 30, in particular the flap-shaped spring. In particular, the spring force is preferably only a few cN, in particular 1 cN or less, most preferably at most 0.5 cN.

  23 and 24 further show an eighth embodiment of the nebulizer 1 of the present invention or the valve device 24 of the present invention. FIG. 23 shows the valve device 24 in a closed state. FIG. 24 shows the valve device 24 in an open state. FIG. 25 is a plan view of the valve element 28 in this case in the form of a plate.

  The valve element 28 is in this case in particular of a rigid structure. In an eighth embodiment, the valve element comprises a central recess designed to allow a central projection with a discharge nozzle 12 to pass as shown in FIG. 23 at least when the valve device 24 is closed. Has an opening. Thus, the inner contour is designed to have the play necessary to fit the protrusion including the discharge nozzle 12 or other part of the nebulizer 1 inside the mouthpiece 13.

  The outer contour of the valve element 28 matches the inner contour of the mouthpiece 13, and in the illustrated embodiment, the shape is elliptical.

  Inside the mouthpiece 13 are an inner O-ring 36 and an outer O-ring 37 arranged concentrically around or under the discharge nozzle 12 in the illustrated embodiment, in particular when the valve device 24 is closed. It forms a sealing valve seat for element 28. In particular, the valve element 28 is adapted to prevent undesired backflow through the air supply opening 15 (in the closed state) upon an O-ring 36, 37 or other suitable seal as a result of its own weight. .

  Upon inhalation, the valve element 28 is lifted as shown in FIG. 24 by receiving pressure, so that the valve 29 formed by the valve device 24 or the valve element 28 is opened. A supply air flow 25 can then flow into the mouthpiece 13 between the central projection containing the discharge nozzle 12 and the central recess of the valve element 28 in the illustrated embodiment.

  In the illustrated embodiment, the O-rings 36 and 37 are held on a suitable annular shoulder, stepped portion or the like provided in the nebulizer 1 or the mouthpiece 13. However, other structural solutions are also possible, especially if other suitable seals are used.

  In order to limit the play or stroke of the valve element 28, the nebulizer 1 of the eighth embodiment preferably has an insert 38 or the like inside the mouthpiece 13, as shown in FIGS. This insert 38 can be of a circumferential structure, if necessary, and this insert is particularly adapted to the preferably oval inner contour of the mouthpiece 13. If necessary, the insert 38 is injection molded in a so-called 2C process, ie a two-part injection process. However, other structural solutions are also possible.

  The radial play of the valve element 28 inside the mouthpiece 13 and the mass of the valve element 28 are configured such that the valve device 24 or valve 29 has the desired easy action. In particular, the above applies in relation to the opening and closing force.

  It should be noted that with the nebulizer 1 of the present invention, the active substance is preferably taken up by inhalation during only one breath. The nebulizer 1 is configured accordingly. Specifically, the nebulizer 1 can generate a sufficiently high droplet or aerosol density and hence the density of the active substance. To be precise, in this type of nebulizer 1, the valve device 24 provided to prevent backflow through the air supply opening 15 allows the entire amount of active substance to be inadvertently when the user exhales. This is particularly important in avoiding the risk of accidental ejection.

  In contrast to self-supporting devices and the like, the nebulizer 1 of the present invention is preferably designed to be portable, in particular a hand-held mobile device.

  Preferably, fluid 2 is a liquid as described above, in particular an aqueous pharmaceutical formulation. However, the fluid may also be a different type of formulation, suspended material, etc.

  According to one variant embodiment, the fluid 2 may be a particle or a powder. In this case, instead of the discharge nozzle 12, another supply device for supplying the fluid 2 or powder or the like to the mouthpiece 13, in particular a discharge opening (not shown) or a supply channel (not shown) may be provided. Good. In this case, the optional air supply opening 15 supplies ambient air, preferably in parallel, thereby creating or allowing air flow in an amount sufficient for inhalation or inhalation within the mouthpiece 13. To help.

  In the previous example and the variant embodiments described above, the supply device, in particular the discharge opening or the discharge nozzle 12, is configured separately from the air supply opening 15 or any other channel supplying the ambient air. Thus, on the one hand there is optionally a parallel supply of fluid 2 or powder etc. together with carrier gas, propulsion gas, carrier air etc. and a surrounding air which generates a sufficient amount of air flow on the other side. However, according to another variant embodiment, this supply may also occur jointly or together, in particular by means of a common opening (not shown) into the mouthpiece 13. For example, the discharge nozzle 12 may be incorporated into the air supply opening 15 for this purpose, or vice versa.

  The valve device 24 of the variant embodiment described above may be associated with the air supply opening 15 and / or the discharge opening or supply channel to avoid unwanted backflow. The valve device 24 is preferably configured in the form of a check valve and / or a check valve, particularly in the case of powders or when generating the particulate aerosol 14.

  It should be noted that the fluid 2 may also be atomized using a propellant gas if desired. Thus, the valve device 24 of the present invention can be used in a nebulizer or inhaler operated by propellant gas.

  Further, the valve device 24 of the present invention or the mouthpiece 13 provided with this valve device is used not only for the nebulizer 1 specifically described above but also for other nebulizers or inhalers, such as powder inhalers or so-called metered dose inhalers. It should be noted that you can.

1 is a schematic cross-sectional view of a known nebulizer in a non-tensioned state. It is a schematic sectional drawing of the well-known nebulizer in the tension state rotated 90 degrees compared with FIG. 1 is a schematic cross-sectional view of details of a mouthpiece of a nebulizer proposed as a first embodiment with a valve device in a closed state. FIG. 4 is an enlarged detail view of FIG. 3 along the dotted line. Fig. 4 is a schematic illustration of the valve device of Fig. 3 in an open state. FIG. 6 is an enlarged detail view of FIG. 5 along the dotted line. It is a schematic sectional drawing of the detail of the mouthpiece of the nebulizer proposed as 2nd Embodiment with a valve apparatus in a closed state. 8 is a schematic illustration of the valve device of FIG. 7 in an open state. It is a schematic sectional drawing of the detail of the mouthpiece of the nebulizer proposed as 3rd Embodiment with a valve apparatus in a closed state. Fig. 10 is a schematic illustration of the valve device of Fig. 9 in an open state. It is sectional drawing corresponding to FIG. 9, and is a figure of the valve apparatus of 4th Embodiment in a closed state. It is sectional drawing of the valve apparatus of FIG. 11 in an open state. FIG. 10 is a cross-sectional view corresponding to FIG. 9 and a view of the valve device of the embodiment of FIG. FIG. 14 is an enlarged detail view of FIG. 13 along the dotted line. It is sectional drawing of the valve apparatus in FIG. 13 in an open state. FIG. 16 is an enlarged detail view of FIG. 15 along the dotted line. It is a schematic sectional drawing of the detail of the mouthpiece of the nebulizer proposed as 6th Embodiment with a valve apparatus in a closed state. It is a top view of the nebulizer of FIG. FIG. 18 is a cross-sectional view of the valve device of FIG. 17 in a closed state. FIG. 20 is a plan view of the nebulizer of FIG. 19. It is a figure which shows the piece of material for forming the valve element of the valve apparatus of 6th Embodiment. It is a schematic sectional drawing of the nebulizer proposed as 7th Embodiment provided with the valve apparatus and related sensor in an open state. It is a schematic sectional drawing of the detail of the mouthpiece of the nebulizer proposed as 8th Embodiment with a valve apparatus in a closed state. FIG. 24 is a cross-sectional view of the nebulizer of FIG. 23 with the valve device in an open state. FIG. 24 is a plan view of a valve element of the valve device of FIG. 23.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Nebulizer 2 Fluid 3 Container 4 Bag 5 Pressure generator 6 Holder 7 Drive spring 8 Locking element 9 Transport pipe 10 Check valve 11 Pressure chamber 12 Discharge nozzle 13 Mouthpiece 14 Aerosol 15 Air supply opening 16 Upper housing part 17 Inner part 17a Upper part of the inner part 17b Lower part of the inner part 18 Housing part (lower part)
19 Holding element 20 Spring (lower housing part spring)
DESCRIPTION OF SYMBOLS 21 Container base 22 Puncture element 23 Monitoring apparatus 24 Valve apparatus 25 Flow of supply air 26 Seat element 27 Through-opening part 28 Valve element 29 Valve 30 Spring (valve apparatus)
31 Guide Element 32 Plate 33 Recess 34 Material Piece 35 Sensor 36 Inner O-ring 37 Outer O-ring 38 Insert

Claims (32)

A nebulizer (1) for a fluid (2) comprising a mouthpiece (13) and at least one air supply opening (15) associated with the mouthpiece (13), wherein the fluid (2) In a nebulizer that can be sprayed into the mouthpiece (13),
The one or more air supply openings (15) are associated with at least one valve device (24) capable of stopping back flow through the one or more air supply openings (15).
Nebulizer characterized by that. The valve device (24) is provided in the mouthpiece (13) and / or arranged side by side on the discharge nozzle (12) for the fluid (2),
The nebulizer according to claim 1. Said valve device is preferably insertable into the mouthpiece (13) as a structural unit, in particular as an add-on,
The nebulizer according to claim 1 or 2. At least one component of the valve device (24) is fixedly attached to the nebulizer (1), in particular the mouthpiece (13),
The nebulizer according to claim 1 or 2. The valve device (24) is preferably exchangeable with the mouthpiece,
The nebulizer according to any one of claims 1 to 4. The valve device (24) operates substantially independently of at least the orientation of the nebulizer (1) in space;
The nebulizer according to any one of claims 1 to 5. The valve device (24) operates only mechanically,
The nebulizer according to any one of claims 1 to 6. Said valve device (24) comprises at least one valve (29) and / or a movable valve element (28),
The nebulizer according to any one of claims 1 to 7. The valve element (28) can move in the longitudinal direction of the nebulizer (1) and / or move in the direction of the supply air flow (25) through one or more air supply openings (15). Can
The nebulizer according to claim 8. Some or all of the air supply openings (17) are associated with a common valve (29) and / or a common valve element (28);
The nebulizer according to claim 8 or 9. A separate valve (29) and / or a separate valve element (28) is associated with each said air supply opening (15).
The nebulizer according to claim 8 or 9. The valve element (28) is in the form of a plate or flap;
The nebulizer according to any one of claims 8 to 11. The valve element (28) is at least substantially rigid in structure;
The nebulizer according to any one of claims 8 to 12. Said valve element (28) is of a flexible structure, in particular of a foil-like structure,
The nebulizer according to any one of claims 8 to 12. Said valve element (28) is biased to the open or closed position, in particular by spring force, inherent elasticity and / or weight,
The nebulizer according to any one of claims 8 to 14. The nebulizer (1) is associated with the valve device (24), in particular the valve element (28) of the valve device (24), and in particular has a sensor (35) for detecting opening and / or closing.
The nebulizer according to any one of claims 1 to 15. The sensor (35) detects the movement or at least one position of the valve element (28) by mechanical, optical, electrical, inductive, capacitive and / or other contactless means. ,
The nebulizer according to claim 16. The sensor (35) is configured as a microswitch or lead contact,
The nebulizer according to claim 16 or 17. The nebulizer (1) counts and / or evaluates the operation of the nebulizer (1) or the sensor (35) opens and / or closes the valve device (24) or the valve element (28). Having a monitor device (23) for detecting whether or not
The nebulizer according to any one of claims 16 to 18. The atomization is not carried out in particular with a propellant gas and is preferably carried out purely mechanically by means of a spring force.
The nebulizer according to any one of claims 1 to 19. The nebulizer (1) has an opening (3) for containing the fluid (2), in particular a liquid, and the nebulizer can move in a stroke, preferably during pressure generation or atomization,
The nebulizer according to any one of claims 1 to 20. Said nebulizer (1) is especially configured as an inhaler for medical aerosol treatment,
The nebulizer according to any one of claims 1 to 21. The nebulizer (1) is configured to atomize the fluid (2) independently of the supply air flow (25) through one or more air supply openings (15).
The nebulizer according to any one of claims 1 to 22. The nebulizer (1) has a supply device for spraying the fluid (2) into the mouthpiece (13), in particular a discharge opening or nozzle (12),
The nebulizer according to any one of claims 1 to 23. The supply device opens into the mouthpiece (13) separately from, preferably in parallel with, the one or more supply openings (15), in particular arranged separately from the supply openings. And / or configured,
25. A nebulizer according to claim 24. The air supply opening (15) is incorporated in the supply device, in particular the air supply opening (15) and the supply device have a common opening into the mouthpiece (13). ,
25. A nebulizer according to claim 24. The mouthpiece (13) is configured according to any one of claims 28 to 32,
27. A nebulizer according to any one of claims 1 to 26. A mouthpiece (13) for an inhaler or nebulizer (11), preferably configured according to any one of claims 1 to 27, wherein the air flow is in an amount sufficient to inhale or inhale. Having a channel or air supply opening (15) for supplying ambient air to generate and having a valve device (24) capable of stopping back flow through the channel or the air supply opening (15);
A mouthpiece characterized by that. The valve device (24) is configured as a check valve and / or a check valve.
The mouthpiece according to claim 28. A supply device, in particular a discharge opening or nozzle (12), for the medium to be atomised, preferably a powder or fluid (2) or an aerosol (14), in particular the channel or the air supply opening (15). Parallel to the mouthpiece (13).
The mouthpiece according to claim 28 or 29. The supply device opens into the mouthpiece (13) separately from, preferably in parallel with, the channel or the air supply opening (15), in particular the channel or the air supply opening (15). ) And / or configured separately from
The mouthpiece according to claim 30. The channel or the air supply opening (15) is integrated into the supply device, in particular the channel or the air supply opening (15) and the supply device into the mouthpiece (13). Having a common opening,
The mouthpiece according to claim 30.

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